Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001053617p
Ethics application status
Submitted, not yet approved
Date submitted
15/08/2023
Date registered
29/09/2023
Date last updated
29/09/2023
Date data sharing statement initially provided
29/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An Educational tool targeting the symptoms of constipation among people prescribed Clozapine.
Scientific title
Addressing the prevalence and severity of clozapine-induced constipation in adults with schizophrenia or schizoaffective disorder using a nurse-delivered education session: A randomised controlled trial
Secondary ID [1] 310365 0
None
Universal Trial Number (UTN)
Trial acronym
CONSTIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 331104 0
Condition category
Condition code
Diet and Nutrition 327889 327889 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 328190 328190 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 328191 328191 0 0
Schizophrenia
Public Health 328192 328192 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a one hour educational session with a registered nurse, and a brochure to take home. The educational material will incorporate definitions of constipation, risk factors, signs and symptoms, and non-pharmacological interventions. Pharmacological interventions will be noted, with a view to consult with their physician regarding medications. The educational intervention will be conducted via one-to-one sessions, alongside a routine appointment with the clozapine clinic. A PowerPoint presentation will be provided, with opportunity following to discuss the subject matter, and answer any questions. The brochure has been specifically been designed for this project. The non-pharmacological interventions consist of commencing or increasing cardiovascular activity via exercise, and increase in fluid intake, and increase in fibre intake, with suggested methods of doing so (foods with known high fibre content) and behavioural modifications - Making a routine to attempt passing stool, making an exercise routine.
Intervention code [1] 326761 0
Treatment: Other
Comparator / control treatment
The control will consist of routine clinical care. This involves screening and assessment by the Clozapine coordinator (registered nurse) and a member of the psychiatry team every 3 months.
Control group
Active

Outcomes
Primary outcome [1] 335735 0
Using the Patient Assessment of Constipation Symptoms (PAC SYM) tool which measures constipation across a spectrum. The primary outcome is to measure possible changes in constipation prevalence across both groups.
Timepoint [1] 335735 0
This occurs across a 3 month period. At the initial consultation, a base measurement will be taken. Then, the participant will record measurements at two week intervals for the total of 12 weeks.
Secondary outcome [1] 425392 0
Secondary outcome would be that consumers prescribed clozapine have a change in their understanding of the signs, symptoms, cause, and treatment of constipation. This will be assessed as a composite outcome, measured with the PAC SYM tool.
Timepoint [1] 425392 0
3 months. This occurs across a 3 month period. At the initial consultation, a base measurement will be taken. Then, the participant will record measurements at two week intervals for the total of 12 weeks.

Eligibility
Key inclusion criteria
A diagnosis of schizophrenia or schizoaffective disorder, prescribed Clozapine.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A formal diagnosis of an intellectual disability, or cognitive disorder, impacting ability to provide informed consent. Similarly, any consumer with an appointed decision maker.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ABS Sample size calculator, with a confidence interval of 95%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2023
Actual
Date of last participant enrolment
Anticipated
4/03/2024
Actual
Date of last data collection
Anticipated
27/05/2024
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 41110 0
2132 - Croydon
Recruitment postcode(s) [2] 41111 0
2193 - Canterbury
Recruitment postcode(s) [3] 41109 0
2204 - Marrickville

Funding & Sponsors
Funding source category [1] 314800 0
Government body
Name [1] 314800 0
Sydney Local Health District
Country [1] 314800 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Health District
Address
67 Missenden Road, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 316846 0
None
Name [1] 316846 0
Address [1] 316846 0
Country [1] 316846 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313603 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313603 0
Sydney Local Health DistrictAddress: Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 313603 0
Australia
Date submitted for ethics approval [1] 313603 0
24/08/2023
Approval date [1] 313603 0
Ethics approval number [1] 313603 0

Summary
Brief summary
consumers prescribed Clozapine suffer from constipation; essentially double that of the general population. Clozapine consumers are 3 times more likely to develop constipation, compared to their contemporaries prescribed other antipsychotics. Ongoing questioning and screening by mental health professionals is strongly recommended, in order to detect and treat constipation in a timely manner. In my experience as a mental health case manager, and more recently as a Clozapine coordinator, the screening, detection, and management of clozapine induced constipation is severely lacking.

Non-pharmacological interventions are considered the first and most important step in managing constipation. One hour of exercise, five days a week; increased fibre and fluid intake. These can be achieved with minimal support clinically, and financially. Clozapine clinics have been seen as a place to develop health agency and providing education during clinics, with a view to have the consumers engage in their own treatment interventions for constipation would be the goal. I would aim to incorporate the peer workforce and current consumers prescribed clozapine in the development of the education aspect.

This RCT will consist of a control and intervention group. The control group will receive current health practices, which include 3 monthly screening and assessment for constipation by a registered nurse and /or physician. The intervention group will receive an hour of education, targeted at improving their knowledge and understanding of constipation, and given them lifestyle interventions to manage it. All participants will complete a 2 weekly constipation self-report measure called the PAC - SYM to collect data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128718 0
Mr Marc Lamond
Address 128718 0
Marrickville Community Mental Health, 155 Livingstone Road, Marrickville, NSW. 2204
Country 128718 0
Australia
Phone 128718 0
+61 2 95620500
Fax 128718 0
+61 2 95620501
Email 128718 0
marc.lamond@health.nsw.gov.au
Contact person for public queries
Name 128719 0
Mr Marc Lamond
Address 128719 0
Marrickville Community Mental Health, 155 Livingstone Road, Marrickville, NSW. 2204
Country 128719 0
Australia
Phone 128719 0
+61 2 95620500
Fax 128719 0
+61 2 95620501
Email 128719 0
marc.lamond@health.nsw.gov.au
Contact person for scientific queries
Name 128720 0
Mr Marc Lamond
Address 128720 0
Marrickville Community Mental Health, 155 Livingstone Road, Marrickville, NSW. 2204
Country 128720 0
Australia
Phone 128720 0
+61 2 95620500
Fax 128720 0
+61 2 95620501
Email 128720 0
marc.lamond@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.